End-Stage Renal Disease Intra-dialysis Lifestyle Education Study (END-IDLE)
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|ClinicalTrials.gov Identifier: NCT02361268|
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease||Behavioral: Intradialysis-yoga Behavioral: Educational program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||End-Stage Renal Disease Intra-dialysis Lifestyle Education Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Intra-dialysis yoga
The experimental intervention in this study is intra-dialysis yoga.
The experimental intervention in this study is intra-dialysis yoga. The intra-dialysis yoga protocol consists of yoga instruction and practice being offered three times a week for 12 weeks. Subjects will have the opportunity to participate in 15 to 60 minutes of yoga during dialysis.
Active Comparator: Educational program
The active comparator for the study is an educational program.
Behavioral: Educational program
The educational intervention in this study consists of 12 modules of an educational course, Kidney School, developed and maintained by the Medical Education Institute, Inc. Kidney School is a comprehensive, free, educational curriculum for people with kid
- Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]The Kidney Disease Quality of Life-36 instrument is a 36-item instrument that contains a generic core (Short Form-12) plus the burden of kidney disease, symptoms/problem of kidney disease, and effects of kidney disease scales.
- Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess fatigue among chronic disease patients
- Profile of Mood States [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess emotional states
- Center for Epidemiological Studies Depression [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess depressive symptoms
- End-stage renal disease: Patient satisfaction [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess patient satisfaction with dialysis treatment
- Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess sleep quality
- Self-efficacy for self-management [ Time Frame: Baseline, 6, 12, and 24 weeks ]Questionnaire to assess self-efficacy for self-management
- 6-minute walk test [ Time Frame: Baseline, 12, and 24 weeks ]Assessment of physical performance
- Blood pressure [ Time Frame: Baseline and weekly over 12 week study period ]
- Measure of endothelial function with flow-mediated vasodilatation [ Time Frame: Baseline and 12-weeks ]Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters
- Measure of arterial stiffness from radial artery based pulse wave analysis [ Time Frame: Baseline and 12-weeks ]Sub-set of patient will have this assessment of arterial stiffness as augmentation index
- Autonomic tone [ Time Frame: Baseline and 12-weeks ]Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361268
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Gurjeet S Birdee, MD MPH||Vanderbilt University Medical Center|